Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide

Alessandra Larocca; Federica Cavallo; Sara Bringhen; Francesco Di Raimondo; Anna Falanga; Andrea Evangelista; Maide Cavalli; Anfisa Stanevsky; Paolo Corradini; Sara Pezzatti; Francesca Patriarca; Michele Cavo; Jacopo Peccatori; Lucio Catalano; Angelo Michele Carella; Anna Maria Cafro; Agostina Siniscalchi; Claudia Crippa; Maria Teresa Petrucci; Dina Ben Yehuda; Eloise Beggiato; Tommaso Caravita Di Toritto; Mario Boccadoro; Arnon Nagler; Antonio Palumbo

doi:10.1182/blood-2011-03-344333

Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide

Blood. 2012 Jan 26;119(4):933-9; quiz 1093. doi: 10.1182/blood-2011-03-344333. Epub 2011 Aug 11.

Affiliation

¹ Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria (AOU) S. Giovanni Battista, Torino, Italy.

PMID: 21835953
DOI: 10.1182/blood-2011-03-344333

Abstract

Lenalidomide plus dexamethasone is effective in the treatment of multiple myeloma (MM) but is associated with an increased risk of venous thromboembolism (VTE). This prospective, open-label, randomized substudy of a phase 3 trial compared the efficacy and safety of thromboprophylaxis with low-dose aspirin (ASA) or low-molecular-weight heparin (LMWH) in patients with newly diagnosed MM, treated with lenalidomide and low-dose dexamethasone induction and melphalan-prednisone-lenalidomide consolidation. Overall, 342 patients who did not have clinical indications or contraindications to antiplatelet or anticoagulant therapy were randomly assigned to receive ASA 100 mg/d (n = 176) or LMWH enoxaparin 40 mg/d (n = 166). The incidence of VTE was 2.27% in the ASA group and 1.20% in the LMWH group. Compared with LMWH, the absolute difference in the proportion of VTE was 1.07% (95% confidence interval, -1.69-3.83; P = .452) in the ASA group. Pulmonary embolism was observed in 1.70% of patients in the ASA group and none in the LMWH group. No arterial thrombosis, acute cardiovascular events, or sudden deaths were reported. No major hemorrhagic complications were reported. In previously untreated patients with MM receiving lenalidomide with a low thromboembolic risk, ASA could be an effective and less-expensive alternative to LMWH thromboprophylaxis.

Trial registration: ClinicalTrials.gov NCT00551928.

Publication types

Clinical Trial, Phase III
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Anticoagulants / adverse effects
Anticoagulants / therapeutic use*
Antineoplastic Agents / administration & dosage
Antineoplastic Agents / adverse effects
Antineoplastic Agents / therapeutic use
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Aspirin / adverse effects
Aspirin / therapeutic use*
Enoxaparin / adverse effects
Enoxaparin / therapeutic use*
Female
Humans
Incidence
Israel / epidemiology
Italy / epidemiology
Lenalidomide
Male
Middle Aged
Multiple Myeloma / drug therapy*
Platelet Aggregation Inhibitors / adverse effects
Platelet Aggregation Inhibitors / therapeutic use*
Pulmonary Embolism / chemically induced
Pulmonary Embolism / epidemiology
Pulmonary Embolism / prevention & control
Risk Factors
Thalidomide / administration & dosage
Thalidomide / adverse effects
Thalidomide / analogs & derivatives*
Thalidomide / therapeutic use
Venous Thromboembolism / chemically induced
Venous Thromboembolism / epidemiology
Venous Thromboembolism / prevention & control*
Venous Thrombosis / chemically induced
Venous Thrombosis / epidemiology
Venous Thrombosis / prevention & control

Substances

Anticoagulants
Antineoplastic Agents
Enoxaparin
Platelet Aggregation Inhibitors
Thalidomide
Lenalidomide
Aspirin

Associated data

ClinicalTrials.gov/NCT00551928